Skip to main content
OpenTrials
Completed

NCT Number: NCT02959021

Partnership Optimizes Weight Management in Primary Care

The purpose of this study is to examine whether a primary care weight management intervention delivered by peer coaches produces greater weight loss than a self-directed program without peer coach support.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 21-75 years
  • Body mass index (BMI) 30-50 kg/m2
  • Receiving primary care services at one of the practices participating in this study

Exclusion criteria

  • Uncontrolled hypertension (blood pressure >160/100 mm Hg at screening)
  • Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; NYHA Class III or IV congestive heart failure; type 1 diabetes; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); and chronic lung diseases that limit physical activity
  • Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, or chemotherapeutic drugs; prescription weight loss medications (past six months)
  • Unwilling or unable to do any of the following: give informed consent; read/understand English; accept random assignment; travel to the intervention site
  • Likely to relocate out of the area in the next 2 years
  • Participation in another randomized research project
  • Weight loss > 10 pounds in past six months
  • History of bariatric surgery

Treatment and study plan

weight loss intervention - self directed

Behavioral

weight loss intervention - peer coach

Behavioral

Primary outcomes

  1. body weight

    Time frame: 6, 12, and 18 months

    change in body weight (kg) from baseline to follow-up assessments

Secondary outcomes

  1. physical activity

    Time frame: 6, 12, and 18 months

    Self-reported physical activity assessed via the Paffenbarger Physical Activity Questionnaire (PPAQ).

  2. treatment adherence

    Time frame: 6, 12, and 18 months

    Treatment adherence will be assessed by the number of treatment sessions and phone calls completed.

  3. treatment burden

    Time frame: 6, 12, and 18 months

    Behavioral burden of treatment will be assessed with self-report questionnaires including items about the perceived burden of behavioral targets such as self-monitoring, dietary changes, maintaining physical activity, and the impact of treatment on social relationships.

  4. treatment satisfaction

    Time frame: 6, 12, and 18 months

    Participants will complete self-report items assessing their attitudes and satisfaction regarding the weight loss intervention and weight loss achieved.

  5. side effects

    Time frame: 6, 12, and 18 months

    Symptom checklist including minor (e.g., constipation, dry mouth) and more severe events (e.g., cardiovascular events) will be administered to assess potential adverse side effects associated with treatment.

  6. quality of life

    Time frame: 6, 12, and 18 months

    Quality of life will be assessed through the validated Short-Form 12 (SF-12), which provides measures of health-related quality of life for physical and mental health.

  7. physical and social functioning

    Time frame: 6, 12, and 18 months

    Items from the Patient Reported Outcome Measurement Information System (PROMIS) will be administered, including the 8-item short forms for physical and social functioning.

  8. mood

    Time frame: 6, 12, and 18 months

    The Patient Health Questionnaire-8 (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered.

  9. healthcare utilization

    Time frame: 6, 12, and 18 months

    Self-reported utilization of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and out-of-pocket costs will be collected.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Primary Care Obesity Management in the Southeast_PROMISE

Acronym: PROMISE

Important dates

Study start
2017
Primary completion
2021
Study completion
2025
First posted
Nov 8, 2016
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.